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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory, With Analysis Algorithm
510(k) Number K051730
Device Name MATRIX HOLTER SYSTEM, MODEL M12
Applicant
Global Instrumentation, LLC
8104 Cazenovia Rd.
Manlius,  NY  13104
Applicant Contact CRAIG SELLERS
Correspondent
Global Instrumentation, LLC
8104 Cazenovia Rd.
Manlius,  NY  13104
Correspondent Contact CRAIG SELLERS
Regulation Number870.2800
Classification Product Code
MLO  
Date Received06/27/2005
Decision Date 09/26/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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